Affiliation: Food and Drug Administration
- Regulatory expectations during product development for tumour vaccinesK Kawakami
Division of Cellular and Gene Therapies, Office of Cellular, Tissue, and Gene Therapies, CBER, FDA, Bethesda, MD 20892, USA
Dev Biol (Basel) 116:53-9; discussion 69-76. 2004..The step-wise approach to regulatory requirements including current good manufacturing practices (cGMPs) and characterization of these vaccines at various stages of product development is discussed...